The scope of this contract is to provide data management, quality assurance, clinical trial monitoring and auditing capability, for NCI sponsored clinical trials at participating sites both within and outside of the U.S and monitoring for current Good Manufacturing Practices (cGMP) for biopharmaceutical manufacturing facilities and Good Laboratory Practices for Core Laboratories performing investigational integral and integrated biomarker assays. The Contractor shall build, maintain, and enhance the operational infrastructure to support the tasks listed within the Statement of Work (SOW). The requirements in this SOW are highly integrated and complex. The multiple dependencies described within the SOW require tight process/system integration to ensure project success. To assist the CTEP in fulfilling its regulatory responsibilities as an IND sponsor and to assure compliance with protocol and regulatory requirements and source data verification, the Clinical Trials Monitoring Service